1. Field of the Invention
This invention relates to an inexpensive and reliable method of utilizing lecithin, which has a cohesive, plastic structure, for making a solid pharmaceutical and/or nutritional dosage form of the type that is suitable for oral administration.
2. Prior Art
Briefly, and in general terms, lecithin is a solid nutrient that is characterized by cohesive and plastic mechanical properties. As will be recognized by those skilled in the art, lecithin is composed of a combination of known phosphatides. In the past, lecithin has been taken orally by many persons as a nutritional supplement in the form of capsules, granules, or liquid. Moreover, lecithin has also been included, in relatively small quantities, in some vitamin tablets in combination with other vitamins and nutrients. What is more, lecithin has also been used as an emulsifier or dispersant, or as a release, antispattering, or browning agent in several food products, such as chocolate, margarine and shortening. Combined with drugs, in low proportions, lecithin has been used as an emulsifier and suspending agent. However, no application is known in which lecithin has been used as a base or carrier material for independently supporting, in solid form, a combination of vitamins and/or other pharmaceutical substances that is to be shaped into a swallowable dosage form.
Tablets and capsules comprise the most common orally administered pharmacological dosage forms. Contrasted to liquids and powders, tablets and capsules offer the advantage of convenience, while enabling a precise dosage to be measured. However, a significant disadvantage of tablets and capsules is that, in addition to one or more active ingredients, the user also receives undesirable, non-active, and often synthetic additives which are utilized during the manufacture of the tablets or capsules. The non-active additives are typically glidants (such as, for example, talc, magnesium stearate, or calcium stearate) which are used to promote flow of the mixture before forming; anti-sticking agents (such as, for example, paraffin, stearic acid, or soaps) to prevent the mixture from sticking to the tableting machine dies; lubricants (such as, for example, talc, magnesium stearate, or calcium stearate) to reduce friction during compression; diluents or fillers (such as, for example, di-calcium phosphate or various sugars) to increase bulk and to make the tablet of swallowable size; binders (such as, for example, ethylcellulose or corn starch) to mechanically hold the tablet together; disintegrants (such as, for example, corn starch, methylcellulose, or wood products) to promote disintegration of the tablets in the gastrointestinal tract.
Capsules are frequency characterized by the same or similar disadvantages that are inherent in the manufacture of tablets, as has been described above. That is, glidants, diluents, fillers, and other inactive substances may be added to the contents of the capsule. Moreover, the material which forms the capsule shell (which material typically consists of between 10% to 30% of the total capsule weight) is also an additive substance, the composition of which may include synthetic materials. By way of one example, the amount of vitamin E in a capsule thereof typically varies between approximately 15% to 75% of the capsule weight. The remaining weight of the vitamin E capsule generally consists of shell material and vegetable oil utilized for encapsulating purposes.
Some consumers object to the relatively large percentages of undesirable, inactive, and often synthetic ingredients incorporated within tablets and capsules. The adverse and undesirable effects that may be produced by the above-mentioned, inactive additives can be magnified, inasmuch as vitamin/mineral supplements in the form of conventional capsules, tablets, and the like, are frequently taken one or more times a day over long intervals of time (i.e. years).